Key messages:

• Clinical trials are used to find out if a new cancer treatment or other new approach is safe and effective.
  
  
• This research is completed in three separate phases, and each phase provides different information about the new treatment or intervention.
  
  
• Older adults should consider all treatment options, including a clinical trial, and age should not be the only factor in a doctor’s or patient’s decision to participate in a clinical trial.

A clinical trial is a way to test a new treatment to prove that it is safe, effective, and possibly better than a standard treatment. The clinical trial may be evaluating a new drug, a new combination of existing treatments, a new approach to radiation therapy or surgery, or a new method of treatment or prevention. And, not all clinical trials test new drugs. Supportive care trials look at new treatments to help people manage certain side effects of cancer and cancer treatment, such as fatigue or pain.

Phases of clinical trials

Clinical research is done in distinct segments called phases. Each phase of a clinical trial is designed to provide different information about the new treatment, such as the dose, safety, and how well it works. The phases are described as phase I, II, and III (one, two, and three). If a new treatment is unsuccessful (such as being unsafe or ineffective) at any stage, it is not moved to the next stage.

• Phase I trials determine a safe and optimal dose and treatment schedule for a drug. These trials are usually available for people with any type of cancer.
  
  
• Phase II trials provide additional information about a treatment’s safety and whether it is effective for treating cancer.
  
  
• Phase III trials define how the drug will be used for cancer treatment. In these trials, the drug is usually compared with a standard treatment and tested in a large number of people.

Learn more about the phases of clinical trials.

Older adults and clinical trials

Many older adults with cancer do not participate in clinical trials for several possible reasons:

• Doctors may be reluctant to offer an older person the possibility of entering a clinical trial.
  
  
• Co-existing medical conditions, such as heart disease or diabetes, may mean an older adult cannot participate in the clinical trial.
  
  
• The older adult may be unable to provide informed consent due to cognitive (ability to think, reason, and recall facts) problems, such as dementia.
  
  
• An older adult may not have a way to get to the appointments needed to participate in the clinical trial.

Patient participation is also affected by the following factors:

• Age
  
  
• Education
  
  
• Financial reasons
  
  
• Preference for a specific treatment
  
  
• Dislike of experimentation
  
  
• Fear of loss of control
  
  
• Inconvenience
  
  
• Fear of loss of quality of life
  
  
• Confidence in the doctor
  
  
• A desire to contribute to medical knowledge

It is important that all treatment options are considered, including clinical trials. Age should not be the only factor used to decide if a person can participate in a clinical trial. Talk with your doctor about the clinical trials open to you. Older adults who have co-existing medical conditions should have a caregiver with them to help explain the information and requirements. Written instructions that outline exactly what to expect from the treatment may also be helpful.

Questions to ask your doctor

Clinical trials for older adults may to be beneficial. However, older adults with cancer are encouraged to ask their doctors the following questions before deciding to enroll in a clinical trial:

• What are the risks and benefits of treatment?
  
  
• What costs are covered by the study, and what will I be responsible for?
  
  
• Are there any additional tests that I will need in order to be evaluated for the study?
  
  
• How frequent are treatments and follow-up visits?
  
  
• If I participate in a clinical trial, will it make me unable to have other treatments?
  
  
• How long will the clinical trial last?
  
  
• How long after completing my current treatment will I be able to participate in the study?
  
  
• How long will it take to find out if the treatment is working?

More Information

Cancer Treatment

Clinical Trials

ASCO Expert Corner: Placebos in Cancer Clinical Trials

Cancer in Older Adults